1、Development , optimization and verification
of Drug analysis methods
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Develop and optimize analytical methods for quality control of GMP production,
including raw materials, intermediates, API and preparations.
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Develop methods for impurity analysis
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Develop methods for chiral purity analysis
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Develop methods for solvent residue Analysis
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Develop Real-time Analysis method for manufacturing process
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Develop methods for process control
- Methodology
verification(Specificity, accuracy,
linearity, LOD, LOQ, etc.)
2、comprehensive analysis
Include
melting point, UV purity, chiral purity, elemental analysis, heavy metal
analysis, inorganic salt analysis, residual solvent analysis, optical rotation
analysis, UV and IR data, IR, pKa, MS/MS and NMR.
We
will issue a complete report on the confirmation and analysis of the structure
of the compound。
3、quality standard
We
can provide quality research services for chemical drugs, new Chinese medicine
and biochemical drugs, on the basis of which the quality standards of drugs can
be formulated and improved.